Epstein Barr virus-specific autologous cytotoxic T lymphocytes do not improve survival in nasopharyngeal carcinoma

Results from the phase 3 VANCE trial showed that the addition of Epstein Barr virus-specific autologous cytotoxic T lymphocytes (EBV-CTL) to chemotherapy (gemcitabine plus carboplatin) in patients with recurrent but incurable and metastatic advanced nasopharyngeal carcinoma (R/M NPC) did not improve survival.

The first-line treatment for EBV-associated R/M NPC is gemcitabine plus carboplatin [1]. EBV-CTL is an autologous T-cell immunotherapy generated from patients’ blood that has shown promising efficacy in combination with standard first-line chemotherapy in patients with R/M NPC [2].

The VANCE trial (NCT02578641) evaluated the efficacy and safety of gemcitabine plus carboplatin followed by EBV-CTL versus gemcitabine plus carboplatin alone. Dr Han Chong Toh (National Cancer Centre, Singapore) presented the first results [3].

A total of 330 patients were enrolled in 5 countries worldwide (R/M NPC predominantly occurs in people with (South East) Asian ethnicity) and 1:1 randomised to receive 6 cycles of chemotherapy alone (1,000 mg/m² gemcitabine, AUC 2 carboplatin on days 1 and 8) or 4 cycles of chemotherapy followed by up to 6 cycles of EBV-CTL. The primary endpoint was overall survival (OS); secondary endpoints included progression-free survival (PFS), objective response rate (ORR), and safety.

The median OS did not differ significantly between the 2 treatment arms: 25.0 months in the chemotherapy plus EBV-CTL arm versus 24.9 months in the chemotherapy alone arm (HR 1.19; P=0.942). However, there was a trend towards improved OS in patients from USA, Taiwan, and Singapore. The addition of EBV-CTL to the standard chemotherapy regimen did not improve median PFS or ORR. The safety profile was identical in both treatment arms.

“EBV-CTL treatment is well tolerated, but does not improve survival in patients with R/M NPC,” concluded Dr Toh.

1. Bossi P, et al. Ann Oncol. 2020;32(4):452–465.
2. Chia W-K, et al. Mol Ther. 2014;22(1):132–139.
3. Toh HC, et al. Randomized phase III VANCE study: Gemcitabine and carboplatin (GC) followed by Epstein Barr virus-specific autologous cytotoxic T lymphocytes (EBV-CTL) versus the same chemotherapy as first-line treatment for advanced nasopharyngeal carcinoma (NPC). Abstract 652O, ESMO Congress 2022, 09–13 September, Paris, France.

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Posted on 17 November 2022